Advisory details
| Item | Details |
|---|---|
| Advisory number | DI21/05 |
| Version number | 2.0 |
| Trim number | D24-13208 |
| Publication date | 13 January 2025 |
| Replaces | DI21/05 v1.0 published December 2021 |
| Compliance with this advisory | Mandatory for Diagnostic Imaging Accreditation Scheme (DIAS) accrediting agencies and diagnostic imaging practices. |
| Information in this advisory applies to |
|
| Key relationship | 2016 DIAS Standard 2.2: Consumer Consent and Information Standard |
| Attachment | Not applicable |
| Notes |
Additional resources:
|
| Responsible officer | Margaret Banks Director, National Standards Phone: 1800 304 056 Email: AdviceCentre@safetyandquality.gov.au |
| To be reviewed | December 2026 |
Purpose
To advise diagnostic imaging practices on the requirements for informed consent.
Issue
The sector has sought clarification on what constitutes informed consent. This is of particular importance in nuclear medicine, transvaginal and transrectal ultrasound procedures as they present a higher risk of patient harm.
Background
Standard 2.2 Consumer Consent and Information of the Diagnostic Imaging Accreditation Standards states prior to a diagnostic imaging procedure being rendered, except in cases of emergency, the diagnostic imaging practice ensures that:
- Patients have access to information about the diagnostic imaging procedure;
- Risks are advised to the patient or substitute decision maker;
- Practice staff obtain and record relevant information about the patient’s health status and individual risk factors;
- Consent for each diagnostic imaging service is obtained from the patient or the substitute decision maker; and
- Patient consent requirements reflect the risk attached to the diagnostic imaging procedure.
All diagnostic imaging services require informed consent.
Informed consent is a legal, ethical, and professional requirement for all imaging practitioners. Good clinical practice involves obtaining informed consent at an appropriate time prior to imaging and documenting the consent in a patient’s medical records.
For consent to be informed, a patient must have enough information about their condition, the imaging services, any relevant benefits and risks, and alternative options. This involves the opportunity for patients to ask questions and discuss concerns.
A person can give informed verbal or written consent. Consent must always be in writing when required by law or by the policies of the state, territory, or healthcare organisations where the person is receiving care.
The most appropriate form of consent depends on the degree of risk and complexity of the diagnostic imaging service. Considerations include the:
- Degree of significance of the treatment, procedure, or intervention in terms of outcomes for the person
- Potential risks of harm and benefits
- Shorter and longer-term consequences for the person
- Complexity of the treatment, procedure, or intervention
- Characteristics of the person giving consent
Requirements
The diagnostic imaging practice must implement a patient consent and information policy, that ensures each patient:
- Has their individual risks for an imaging service assessed
- Participates in an informed consent process with an imaging practitioner[1] who understands the imaging service the patient is to undergo
- Has their verbal or written informed consent documented in the record of patient care. [2].
Nuclear Medicine Imaging Procedures
Nuclear medicine providers are to have a policy that outlines the procedures it provides that are high risk. The insertion of an intravenous cannula does not of itself present a significant risk that would require written consent.
Obtain informed consent in writing for nuclear medicine imaging procedures that are high-risk.
For most patients, administering a radiopharmaceutical for a nuclear medicine imaging procedure is not high-risk when performed in line with appropriate professional evidence based guidelines.
Transvaginal and transrectal ultrasound procedures
Verbal informed consent is sufficient for low-risk transvaginal and transrectal ultrasound procedures.
The diagnostic imaging practice must obtain written consent for all high-risk procedures, such as those which use transvaginal or transrectal scanning for interventional procedures (including biopsies) or are determined to be high-risk for the individual patient..
For more information
For more information on informed consent is available at:
For guidance on evidentiary requirements for Standard 2.2, see the DIAS User Guide for Practices Applying for Accreditation.
